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Ultrasound Perfusion Measurement for Peripheral Artery Disease

N/A
Waitlist Available
Led By Azra Alizad, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Patients with lower leg amputation
Having ulcer and any health condition that does not allow proper use of ultrasound scanning
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial will test whether ultrasound can show if a treatment for peripheral artery disease is working by measuring changes in the microvessels and perfusion.

Who is the study for?
This trial is for men and women over 18 who have symptoms of claudication, which often indicates peripheral arterial disease (PAD), and are scheduled for vascular testing. It's not suitable for patients with gangrene, lower leg amputations, ulcers, or conditions that prevent ultrasound use. Vulnerable populations are also excluded.
What is being tested?
The study is exploring the effectiveness of an ultrasound technique to track how PAD progresses and responds to treatment by looking at changes in tiny blood vessels and blood flow.
What are the potential side effects?
Since this trial involves non-invasive ultrasound imaging, there are minimal side effects expected. However, some individuals might experience discomfort during the procedure.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had an amputation below the knee.
Select...
I have an ulcer or a condition that prevents ultrasound use.
Select...
I have gangrene.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Aim 1: Determine the efficacy of ultrasonic perfusion imaging for early detection of PAD. The goal is to quantify the perfusion of cuff muscle in patients with lower leg claudication and compare the results to those obtained in healthy individuals
Secondary study objectives
Aim 2: Determine the efficacy of ultrasonic perfusion imaging for assessment of treatment response in PAD patients. The goal is to quantify the perfusion of the cuff muscle in PAD patients in 3 time points, 6 months, and every year after treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Early detection of PAD, assessment of the disease progression and treatment responseExperimental Treatment1 Intervention
The objective of this arm of the study is to evaluate the potentials of Ultrasound Perfusion imaging technique for early detection of peripheral arterial disease in patients and assess the disease progression and monitor the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative perfusion estimation of calf muscle that would separate PAD from non-PAD and help early detection of PAD and would help monitoring the disease progression and treatment response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ultrasound
2013
Completed Phase 1
~4090

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,265 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
100 Patients Enrolled for Peripheral Arterial Disease
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,027 Total Patients Enrolled
53 Trials studying Peripheral Arterial Disease
108,902 Patients Enrolled for Peripheral Arterial Disease
Azra Alizad, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
2,240 Total Patients Enrolled

Media Library

Early detection of PAD, assessment of the disease progression and treatment response Clinical Trial Eligibility Overview. Trial Name: NCT04755335 — N/A
Peripheral Arterial Disease Research Study Groups: Early detection of PAD, assessment of the disease progression and treatment response
Peripheral Arterial Disease Clinical Trial 2023: Early detection of PAD, assessment of the disease progression and treatment response Highlights & Side Effects. Trial Name: NCT04755335 — N/A
Early detection of PAD, assessment of the disease progression and treatment response 2023 Treatment Timeline for Medical Study. Trial Name: NCT04755335 — N/A
~42 spots leftby Mar 2026
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